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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 201-911-8 | CAS number: 89-48-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 33.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 420 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 8 h exposure time, extrapolation from 50% bioavailability oral to 100% bioavailability inhalation, no inhalation study available. Corrected inhalatory NOAEC = 476 mg/kg bw/day*(1/0.38 m3/kg/day)*(50%/100%)*(6.7 m3 (8h)/10 m3 (8h)) = 420 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NO(A)EL
- AF for differences in duration of exposure:
- 1
- Justification:
- no extrapolation from chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not for concentrations
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 476 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- assumed that rat oral and dermal absorptions are equal to human oral and dermal absorption
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NO(A)EL
- AF for differences in duration of exposure:
- 1
- Justification:
- no extrapolation from chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The long-term inhalation DNEL for systemic effects is derived from the chronic oral toxicity study (103-week feeding study) conducted with the read across substance DL-menthol resulting in a NOAEL > 476 mg/kg bw/day for Menthyl acetate. Route-to-route (oral-inhalation) extrapolation was performed. The calculated DNEL is 33.6 mg/m³, applying the assessment factor of 12.5.
The acute/short term inhalation DNEL for systemic effects was not required, since the substance is unlikely to exhibit significant acute inhalation toxicity. Please refer to the waiver for the acute inhalation toxicity study for more discussion (section 7.2.2).
The long-term inhalation DNEL for local effects was not derived, since no hazard was identified based on absence of local irritation potential from skin and eye irritation studies.
The acute/short term inhalation DNEL for local effects was not derived, since there is no hazard identified. From the skin and eye irritation study it is known that Menthyl acetate shows no irritating properties and therefore has no hazard for local effects.
The long-term dermal DNEL for systemic effects is derived also on the basis of the same chronic oral toxicity study (103-week feeding study). For the route-to-route extrapolation it was assumed that oral and dermal absorption in the rat are equal to human oral and dermal absorption. The calculated DNEL is 9.5 mg/kg bw/day, applying the assessment factor of 50.
The acute/short term dermal DNEL for systemic effects was not required, since the substance showed no acute dermal toxicity and the hazard was not identified.
The long-term dermal DNEL for local effects was not derived, since no hazard was identified based on absence of skin sensitising or skin irritating potential.
The acute/short term dermal DNEL for local effects was not derived, since there is no hazard identified. From the skin irritation study it is known that Menthyl acetate shows no irritating properties and therefore has no hazard for local effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 207 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 24 h exposure time, extrapolation from 50% bioavailability oral to 100% bioavailability inhalation, no inhalation study available. Corrected inhalatory NOAEC = 476 mg/kg bw/day*(1/1.15 m3/kg/day)*(50%/100%) = 207 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NO(A)EL
- AF for differences in duration of exposure:
- 1
- Justification:
- no extrapolation from chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not for concentration
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 476 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- assumed that rat oral and dermal absorptions are equal to human oral and dermal absorptions
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- no extrapolation from chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 476 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no route-to-route extrapolation performed
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NO(A)EL
- AF for differences in duration of exposure:
- 1
- Justification:
- no extrapolation from chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The long-term inhalation DNEL for systemic effects is derived from the chronic oral toxicity study (103-week feeding study) conducted with the read across substance DL-menthol resulting in a NOAEL > 476 mg/kg bw/day Menthyl acetate. Route-to-route (oral-inhalation) extrapolation was performed. The calculated DNEL is 8.3 mg/m³, applying the assessment factor of 25.
The acute/short term inhalation DNEL for systemic effects was not required, since the substance is unlikely to exhibit significant acute inhalation toxicity. Please refer to the waiver for the acute inhalation toxicity study for more discussion (section 7.2.2).
The long-term inhalation DNEL for local effects was not derived, since no hazard was identified based on absence of local irritation potential from skin and eye irritation studies.
The acute/short term inhalation DNEL for local effects was not derived, since there is no hazard identified. From the skin and eye irritation study it is known that Menthyl acetate shows no irritating properties and therefore has no hazard for local effects.
The long-term dermal DNEL for systemic effects is derived also on the basis of the same chronic oral toxicity study (103-week feeding study). For the route-to-route extrapolation it was assumed that oral and dermal absorption in the rat are equal to human oral and dermal absorption. The calculated DNEL is 4.8 mg/kg bw/day, applying the assessment factor of 100.
The acute/short term dermal DNEL for systemic effects was not required, since the substance showed no acute dermal toxicity and the hazard was not identified.
The long-term dermal DNEL for local effects was not derived, since no hazard was identified based on absence of skin sensitising or skin irritating potential.
The acute/short term dermal DNEL for local effects was not derived, since there is no hazard identified. From the skin irritation study it is known that Menthyl acetate shows no irritating properties and therefore has no hazard for local effects.
The long-term oral DNEL for systemic effects is derived from the chronic oral toxicity study (103-week feeding study) with read across substance DL-menthol giving a NOAEL > 476 mg/kg bw/day for Menthyl acetate. The calculated DNEL is 4.8 mg/kg bw/day, applying the assessment factor of 100.
The acute/short term oral DNEL for systemic effects was not required, since the substance showed no acute oral toxicity and the hazard was not identified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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